Bupivacaine Epiphora Trial

Epiphora Clinical Trial

Official title:

Improving Epiphora & Ptosis With Bupivacaine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03266081
• Other study ID #: HS#: 14-00614
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: August 23, 2022

Study information

• Verified date: August 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

Exclusion Criteria:

Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.

Related Conditions & MeSH terms

• Epiphora
• Lacrimal Apparatus Diseases
• Ptosis

Intervention

Drug:
• 0.75% bupivacaine
topical anesthetic

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Lacrimal Tear Lake at 6 months	Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye	measurements at baseline and 6 months
Secondary	Change from baseline Lid distraction at 6 months	distance (in mm) that the eyelids can be maximally pulled from the globe	measurements at baseline and 6 months
Secondary	Change from baseline Lid snap back at 6 months	Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers	measurements at baseline and 6 months